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Check List of Batch Record

The document is a chronological check list of batch records from Leon Pharmaceuticals Limited. It contains 30 items that must be checked for each batch, including manufacturing records, cleaning labels for equipment, material requisitions, yield calculations, analytical reports, and quality assurance reports. The checklist provides spaces to record whether each item is available, checked, and the name of the person who approved the batch records.

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4K views2 pages

Check List of Batch Record

The document is a chronological check list of batch records from Leon Pharmaceuticals Limited. It contains 30 items that must be checked for each batch, including manufacturing records, cleaning labels for equipment, material requisitions, yield calculations, analytical reports, and quality assurance reports. The checklist provides spaces to record whether each item is available, checked, and the name of the person who approved the batch records.

Uploaded by

ShagorShagor
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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LEON PHARMACEUTICALS LIMITED

Satkhamair, Sreepur, Gazipur.

Department Quality Assurance


Title Chronological Check List of Batch Records

Document No. Version Effective Date Page


01 of 02
QA/FORM/001 01 01-04-2013

PRODUCT : PRODUCT :
NAME CODE
Batch Size : % of Yield :
MFG. Date : EXP. Date :

AVAILABLE
Yes
Sl. No. BATCH RECORDS CHECKED BY
No X
N/A N/A
01 Manufacturing Requisition

02 Dispensing Booth Cleaned Label

03 Batch Manufacturing Record [pages _____ to ______]

04 In-Process Analysis Request & Report Sheet

05 Vibration Shifter Cleaned Label

06 Mass Mixture Cleaned Label

07 Fluid Bed Cleaned Label

08 Multi-Mill Cleaned Label

09 Blending Cleaned Label

10 Liquid Manufacturing Vat Cleaned Label

11 Filter Press Cleaned Label

12 Compression Machine Cleaned Label

13 Coating Machine Cleaned Label

14 Capsule Loading Machine Cleaned Label

15 Capsule Filling Machine Cleaned Label 02 of 02

Prepared By Checked By Approved By

_____________________ ___________________ ____________________


QC Officer Asst. Manager, QC Deputy Manager, QA
Date: Date: Date:
LEON PHARMACEUTICALS LIMITED
Satkhamair, Sreepur, Gazipur.

Department Quality Assurance


Title Chronological Check List of Batch Records

Document No. Version Effective Date Page


QA/FORM/001 01 01-04-2013

AVAILABLE
Yes
Sl. No. BATCH RECORDS CHECKED BY
No X
N/A N/A
16 Powder Filling Machine Cleaned Label

17 Liquid Filling Machine Cleaned Label

18 Security Foil Sealing Machine Cleaned Label

19 Cap Sealing Machine Cleaned Label

20 Packaging Material Requisition

21 Batch Packaging Record [Pages _____ to ______]

22 Blister Machine Cleaned Label

23 Batch Printing Machine Cleaned Label

24 Finished Product Transfer Note

25 Additional Material Requisition / Material Issuance (if any)

26 Yield Calculations: After Blending __________

After Compression __________

After Filling ___________

After Packaging __________

27 Deviations (if any)

28 Approved Changes (if any)

29 Analytical Report of Finished Product

30 Quality Assurance Report of Finished Products

Prepared By Checked By Approved By

_____________________ ___________________ ____________________


QC Officer Asst. Manager, QC Deputy Manager, QA
Date: Date: Date:

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